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Collaborative Drug Therapy Management in NYS:
Impact on Pharmacy Practice
Kimberly Zammit, PharmD, BCPS, FASHPNYS Board of Pharmacy
Chair, CDTM Implementation Committee
September 23, 2014
Disclosures None to report
Collaborative Drug Therapy ManagementACCP Position Statement
Agreement between one or more physicians and pharmacists
Qualified pharmacists working within the context of a defined protocol are permitted to assume professional responsibility for: Performing patient assessments Ordering drug therapy-related laboratory tests Administering drugs Selecting, initiating, monitoring, continuing, and
adjusting drug regimens. (aka prescribing)
Pharmacotherapy 2003;23:1210-1225
Any setting
Health-systems
Very limited in any setting
No CDTM
CDTM in the U.S. 2012
http://www.cdc.gov/dhdsp/pubs/docs/Pharmacist_State_Law.PDF
Giberson S, Yoder S, Lee MP. Improving Patient and Health System Outcomes through Advanced Pharmacy Practice. A Report to the U.S. Surgeon General.Office of the Chief Pharmacist. U.S. Public Health Service. Dec 2011.http://www.usphs.gov/corpslinks/pharmacy/sc_comms_sg_report.aspx
Report to the Surgeon GeneralObjectives Obtain advocacy from the U.S. Surgeon General to:
Acknowledge pharmacists that manage disease through medication use and deliver patient care services, as an accepted and successful model of health care delivery in the United States, based on evidence-based outcomes, performance-based data and the benefits to patients and other health system consumers.
Recognize pharmacists, who manage disease and deliver many patient care services, as health care providers. One such action is advocate to amend the Social Security Act to include pharmacists among health care professionals classified as “health care providers.”
Have pharmacists recognized by CMS as Non-Physician Practitioners in CMS documents, policies, and compensation tables commensurate with other providers, based on the level of care provided.
Advance beyond discussion (and numerous demonstration projects) of the expanded roles of pharmacist-delivered patient care and move toward health system implementation
Benefit to Cost Ratio (US dollars)
1988 - 1995 1996 - 2000 2001 - 2005
Lowest 1.08 : 1 1.70 : 1 1.02 : 1
Highest 75.84 : 1 17.01 : 1 34.61 : 1
Median 4.09 : 1 4.68 : 1 4.81 : 1
Mean 16.70 : 1 5.54 : 1 7.98 : 1
Report to the Surgeon GeneralEconomic Benefit
Response from the Surgeon General Publically supports the role of pharmacists in
collaborative practice Evidence and outcomes presented support the
following: Health-care leadership and policy makers should
explore ways to optimize the role of pharmacists through collaborative practice
Collaborative practice will improve quality, contain costs and increase access to care
Recognition of pharmacists as health care providers, clinicians and an essential part of the health care team is appropriate given the level of care they provide in many settings
Compensation models reflective of the range of care provided are needed for sustainability
http://www.usphs.gov/corpslinks/pharmacy/sc_comms_sg_report.aspx
NYS CDTM Demonstration Project
NYS CDTM Demonstration Project Report CDTM legislation passed in 2011required the
development of a report: Review the extent to which CDTM was
implemented in New York State Examine whether and the extent to which CDTM
contributed to the improvement of quality of care for patients, reduced the risk of medication error, reduced unnecessary health care expenditures and was otherwise in the public interest.
Make recommendations regarding the extension, alteration and/or expansion of these provisions
Make any other recommendations related to the implementation of CDTM
http://www.op.nysed.gov/news/cdtmreportmay2014final.pdf
CDTM Report Writing Committee Board of Pharmacy
CDTM Implementation Committee
Kimberly Zammit, PharmD, BCPS, FASHP
Leigh Briscoe-Dwyer, PharmD, BCPS, FASHP
Lawrence Mohkiber, RPh, MS
Kimberly Leonard, RPh
Participant Representatives Kelly Rudd, PharmD,
BCPS,CACP Bassett Healthcare
Lisa Phillips, PharmD, CACP, BAAP Upstate Medical Center
Mark Sinnett, PharmD, FASHP Montefiore Medical
Center
CDTM Demonstration Sites*Institution / Location ProgramAnthony Jordan Health Center / Rochester DiabetesBassett Healthcare Network / Cooperstown AnticoagulationBronx-Lebanon Hospital Center / Bronx Heart Failure
Brooklyn Hospital Brooklyn
AnticoagulationAsthma
DiabetesHeart Failure
HIV
Kingsbrook Jewish Medical Center / Brooklyn Anticoagulation
Memorial Sloan Kettering Cancer Center / New York Oncology
Montefiore Medical Center / Bronx Heart FailureRochester General Hospital / Rochester DiabetesRoswell Park Cancer Institute / Buffalo OncologyUnited Health Services / Binghamton AnticoagulationUpstate Medical Center / Syracuse Diabetes
* Programs submitting data
CDTM Demonstration Project Results
Program Number of Patients
Results
Anticoagulation 841
TTR 71 – 84% Low rate of adverse effects
Asthma 25100% patients receiving therapy demonstrated to improve disease control
Diabetes 195
HbA1C Control22 – 39% at goal 7 – 15 % decrease in 4 – 12 months
Heart Failure 7830 Day Hospitalization: 0 – 9 %ACEI / ARB: 88%Beta Blocker: 95%
HIV 864 visitsInterventions optimized efficacy, safety and adherence
Oncology2304
interventions12 patients
Interventions optimized efficacy, safety and adherence
Anticoagulation
Anticoagulation ManagementTime in Target Range
Measure Outcome at 5% increase in TTR
Outcome at 10% increase in TTR
Adverse Events Prevented 1114 2087
Number of Deaths Avoided
662 1233
Number of Quality-Adjusted Life Years Gained
863 1606
Healthcare Dollars Saved (per 67,000 patients)
$15.9 million $29.7 million
Rose AJ, et al. Circ Cardiovasc Qual Outcomes. 2011; 4:416-424.
Anticoagulation ManagementBassett
Healthcare
Brooklyn Hospital
Kingsbrook Jewish
United Health
Usual Care
Number of Patients
503 174 43 121
Age Range (years)
25-97 23-91 22-88 35-88
Medicaid (N)
6 16 NR 25
Medicare (N)
393 60 19 95
ADEs (per 100 patients)
4.97 3.45 2.32 0.82 19.5
TTR 84.6% 75.1% 71.2%Unable
to report57.4%
Anticoagulation Participants Kelly Rudd, PharmD,
BCPS,CACP Bassett Healthcare
Valery L. Chu, PharmD, BCACP, CACP Kingsbrook Jewish Medical
Center Henry Cohen, MS, PharmD,
FCCM, BCPP, CGP Kingsbrook Jewish Medical
Center Lindsey Wormuth, PharmD
United Health Services Hospitals
Rebecca Arcebido, PharmD, BCACP Patient Centered Medical
Home The Brooklyn Hospital Center
Julie Anne Billedo, PharmD, BCACP Patient Centered Medical
Home The Brooklyn Hospital Center
Robert DiGregorio, PharmD, BCACP The Brooklyn Hospital Center
Diabetes
Demographics
Site Number of Patients
Average Patient Age +/- SD (range)
AJHC 60 60.4 ± 10.2 (38 – 83)
Upstate 76 54 ± 11 (29-86)
RGH 24 58.9 + 7.99 (52-70 )
Brooklyn 35 NR
Target Hemoglobin A1C
Site 1 Baseline
Site 1 12 months
Site 2 Baseline
Site 2 12 months
Site 3 Baseline
Site 3 4 months
0%
10%
20%
30%
40%
50%
60%
70%
25%
53%
24%
63%
32%
54%
Perc
en
t P
ati
en
ts w
ith
H
bA
1c<
8%
Change in Hemoglobin A1C
Diabetes Participants Lisa Phillips, PharmD, CACP,
BAAP St John Fisher College /
WSOP Upstate Medical
University Mary Jo Lakomski, BS
Pharm, CDE, BCACP Upstate University
Hospital Robert DiGregorio, PharmD,
BCACP The Brooklyn Hospital
Center
Alex DeLucenay, PharmD, BCACP St John Fisher College,
WSOP Rochester General
Hospital Asim M. Abu-Baker,
PharmD, CDE St. John Fisher College,
WSOF Anthony Jordan Health
Center
Heart Failure
Demographics
Number (%) Mean SDAge 59 64.2 years 12.8Gender: Male 32 (54%) n/a n/aEjection fraction (EF) 57 (97%) 34.1% 11.6N-terminal Pro-BNP 48 (81%) 7165.5
pg/mL 11128
Serum creatinine 52 (88%) 1.7 mg/dL 1.4
Re-Hospitalization 30 days
Among 22 patients who were seen at the clinic within two weeks after discharge, the 30-day readmission rate was 9% (2 /22).
90 days 42 patients had at least one hospitalization in the
prior 3 mos Five patients (12%) have not reached the three month
time point 28 patients (67%) were not hospitalized In comparison to the previous 3 months:
Three patients (7%) had one less hospitalization Two patients (4.5%) had one more hospitalization Four patients (9.5%) had one hospitalization prior to and
one hospitalization after their clinic visits
Pharmacist Interventions
Corrected improper use of medications
Reconciled duplicate medications
Switched patient to appropriate therapy
Discontinued expired/inappropriate medications
Addressed adherence
0 10 20 30 40 50 60
Therapy Optimization
Initiated ACEI/ARB
Uptitrated ACEI/ARB
Uptitrated Beta blocker
Initiated Diuretic
Uptitrated Diuretic
Initiated AA
Initiated ISDN/Hydralazine
0 5 10 15 20 25 30 35 40
Adherence Problems Resolved
Does not un-derstand direc-tionsPrefers not to take medicationForgets to take medicationDrug is unavailable Patient cannot af-ford medication
Heart Failure Participants Angela Cheng, PharmD,
BCPS Montefiore Medical
Center Danielle Garcia, PharmD,
BCPS Montefiore Medical Group
– Bronx East
Charnicia E. Huggins, PharmD, MS Touro College of
Pharmacy Bronx Lebanon Hospital
HIV
Pharmacist Interventions
Intervention Category N = 1408(% of total)
Optimization of therapy by indication 532(37.8)
Unnecessary Drug Treatment 66 (4.6)
Need for Additional Treatment 466 (33)
Optimization of effectiveness 146(10.4)
Inadequate Dose 146(10.4)
Optimization of Safety 165(11.7)
Adverse Reaction (prevented/identified) 112 (8)
Excessive Dose 53 (3.8)
Adherence 444(31.5)
Patient Satisfaction
0
1
2
3
4
3.74 3.64 3.62
1 = Strongly disagree 2 = Somewhat disagree 3 = Somewhat agree 4 = Strongly agree
HIV Participant Agnes Cha, PharmD, AAHIVP, BCACP
Arnold and Marie Schwartz School of Pharmacy and Health Sciences / Long Island University
The Brooklyn Hospital Center
Oncology
Pharmacist InterventionsMemorial Sloan Kettering Cancer Center
Intervention CategoryN = 2392
(% of total)
Optimization of therapy by indication 1235(51.6)
Discontinue Unnecessary Drug Treatment 482 (20.1)Discontinue Duplicative Therapy 37 (1.5)
Initiate Therapy for Untreated Indication 716 (29.9)
Optimization of effectiveness 694(16.5)
Incorrect Dose 627 (26.2)Inappropriate route 67 (2.8)
Optimization of Safety 363(15.1)
Excessive Dose 119 (5)Dangerous Drug Interactions 244 (10.2)
Provider SatisfactionMSKCC
Improves Efficiency
Optimizes Care
Reinforces physician/pharmacist relationship
Overall Satisfied with CDTM program
0 25 50 75 100
Agree Column1
Pharmacist InterventionsRoswell Park Cancer Institute
Advised patient to con-tinue therapyPatient medication counselingAdded new therapeutic agentChanged medication dose
Provider SatisfactionRPCI
Overall Satisfaction with CDTM Services
CDTM Services allows me more time to see patients
Clinical Pharmacy Specialist displayed adequate knowledge
CDTM Services should be continued
CDTM Services improves quality of care
0 10 20 30 40 50 60 70 80 90 100
Very Satisfied/Strongly Agree/ Definitely YesSatisfied/Agree/ProbablyUndecidedDissatified/Disagree/Probably notVery Dissatified/Strongly Disagree/Definitely Not
Patient SatisfactionRPCI
Likelihood of scheduling another pharmacist visit
Pharmacist follow up was appreciated
Pharmacist was well informed and able to answer my questions
Comfortable talking to the pharmacist / asking medication questions
Overall Rating of Pharmacist Services
0 20 40 60 80 100
Very Satisfied/Strongly Agree/ DefinitelySatisfied/Agree/ProbablyUndecidedDissatified/Disagree/Probably NotVery Dissatified/Strongly Disagree/Definitely Not
Oncology Participants Elizabeth Hansen PharmD,
BCOP Roswell Park Cancer
Institute
Richard Tizon, PharmD, BCOP Memorial Sloan-Kettering
Cancer Center
Asthma
Pharmacist InterventionsParameter Frequency
Receiving a controller medication 25(100%)
Rescue medication prescribed 25(100%)
Asthma action plan reviewed and educated 25(100%)
Medication directions reinforced(Patient did not initially demonstrate understanding)
25(100%)
Optimization of Medication Therapy
Additional medication needed to optimize therapy 2(8%)
Unnecessary medication discontinued 1(4%)
Potentially harmful medication discontinued 1(4%)
Asthma Participant Robert DiGregorio, PharmD, BCACP
The Brooklyn Hospital Center
Economic Outcomes
CDTM Demonstration ResultsEconomic Impact
Asthma
Anticoagulation
Heart Failure
Diabetes
0 200 400 600 800 1000 1200 1400 1600
Estimated Annual Savings (millions)
Patient Satisfaction Survey
CDTM Demonstration ResultsPatient Satisfaction Survey
Yes; 96%
No; 1% Unsure; 3%
Care Improved with Pharmacist on Healthcare Team (n=124)
CDTM Demonstration ResultsPatient Satisfaction Survey
Pharmacist Relationship
Disease or Medication Understanding
Adequate time spent with patient
Overall quality of care
Excellent Very Good Good
Patient Satisfaction Comments“Exceptional personnel”
“Feeling better since being here”“I get to know more about my medication and its effectiveness”
“My care is exceptional from my pharmacist”“Saved my life. Saved my sister’s life. I'm thankful for the
patience and taking the time with me”“Pharmacists give you a better understanding of what your meds
is supposed to do”“She is very patient and understanding with me. I enjoy her
being the one helping me”
Conclusions Collaborative management drug therapy
services provided in this pilot program demonstrated: Ability of pharmacists to meet or exceed efficacy
endpoints Reduced risk of adverse reactions and
hospitalizations Optimized medication management Reduced expenditures to the health care system High rates of satisfaction by both patients and
physicians Recommendations
CDTM should be expanded to allow all qualified pharmacists to participate
Collaborative Drug Therapy Management in NYS:
Proposed Legislation
Leigh Briscoe-Dwyer, PharmD, BCPS, FASHPNYS Board of Pharmacy
CDTM Implementation Committee
September 23, 2014
Proposed Legislation Would add additional practitioners who may
enter into CDTM agreements with pharmacists NPs PAs Adds the term “Facility”
Proposed Legislation CDTM can take place in any facility or practice Facility is defined as
Hospital Diagnostic Center Treatment Center Hospital based outpatient department Residential Health Care Facility Nursing Home
Practice shall mean a place or situation in which physicians, physician assistants and nurse practitioners, either alone or in group practices, provide diagnostic and treatment care for patients
Proposed Legislation Includes verbiage on “prescribing” in order to
adjust or manage a drug regimen of a patient, pursuant to a patient specific order or non-patient specific protocol.
Evaluating and ordering disease state and laboratory tests related to drug therapy management of the disease or disease states specified within a protocol
Performing routine patient monitoring functions as may be necessary (Vitals)
No Informed Consent No Sunset
Pharmacist Credentials Must have a current unrestricted license in NY Satisfy any two (2) of the following:
Certification in a relevant area of practice from an organization recognized by ACPE or another entity recognized by the State Education Department
Postgraduate residency through an accredited postgraduate institute At least 50% of the experience includes the provision of direct
patient care with interdisciplinary teams Have provided clinical services to patients for at least 1
year Pharmacists who meet the experience requirements
will be certified by State Education Department to enter into CDTM agreements
Pharmacist Credentials: Experience Provision of clinical services to patients for at
least one year Under a collaborative practice agreement with a
physician or other recognized provider, OR Has documented experience in the provision of
clinical services to patients for at least one year and deemed acceptable to the department upon recommendation of the board of pharmacy
A licensed pharmacist may engage in CDTM under the supervision of a CDTM pharmacist in order to gain experience necessary to qualify to participate
Why credentialing in pharmacy? Increasing complexity in healthcare
Technology advancement Expectation of pharmacist involvement in patient
care teams Participation / management of advanced practice
activities
Demand for safe, effective and high quality care IOM report – licensure/CE inadequate Consumer group/public demand Scrutiny by hospital quality and risk departments
Credentialing Credentialing “Ensures”:
Documented evidence of professional qualifications
Demonstration that they possess the knowledge to manage certain disease states
Examples: Academic degrees State licensure Residency diplomas Certifications
eg. BCPS, BCOP, BCPP, BCNSP, BCNP, BCACP, CDE, AE-C, CACP
Certificate Programs (ASHP, ACCP, NYSCHP)
Board Certification Pharmacist-only
Board of Pharmaceutical Specialties (BPS) Ambulatory, Cardiology (AQ), ID (AQ), Nuclear,
Nutrition Support , Oncology, Pharmacotherapy, Psychiatry
BPS is by the National Commission for Certifying Agencies
Pediatric and Critical Care Fall 2015 Commission for Certification in Geriatric
Pharmacy Certified Geriatric Pharmacist
Multidisciplinary Various certification bodies
Anticoagulation, Asthma, BLS/ACLS, Clinical Pharmacology, Diabetes (education and management), Health Information Technology, HIV, Lipids, Pain (education and management), Poison information, Toxicology
http://www.pharmacycredentialing.org/Files/CertificationPrograms.pdf
http://www.pharmacycredentialing.org/Files/CertificationPrograms.pdf
Spectrum of Clinical Practitioners
Generalist Practitioner
Focused Practitioner
Wide variety of patients and diseases; minor
ailments to more complex conditions
Wide variety of diseases in a unique setting or
population, or a narrow disease focus
Advanced Generalist Practitioner
Advanced Focused Practitioner
Wide variety of patients and diseases; complex
healthcare issues
Focused patient populations; medically
complex patients, therapies, and/or
technology
Breadth of patient / practice focus
http://www.pharmacycredentialing.org/Contemporary_Pharmacy_Practice.pdf
Level o
f know
ledge, skills a
nd
experie
nce
Bro
ad
Narro
wEntr
y level
Advanced
Why Residency Training? Allows training as a licensed practitioner
under the supervision of an experienced preceptor
Develops skills specific to the management of drug therapy in a systematic fashion Direct patient care and practice management
Supported by ACCP and ASHP 2020 Goal: All pharmacists that provide direct
patient care will have completed a PGY1 residency Expansion of residency programs will be
necessary to achieve this goal Residency equivalency process / practice
portfolioPharmacotherapy 2009;29(12):399e–407e
PGY 1 Residency TrainingSupply vs. Demand
Current Legislation Status